Senior Medical Writer

San Diego, CA

  • Samumed is looking for a Sr. Medical Writer to join our Regulatory Affairs team.
  • The Sr. Medical Writer is responsible for writing, reviewing, and overseeing the production of clinical, non-clinical, and regulatory documents in support of drug development programs.

Specific Responsibilites

  • Working directly to support the clinical, non-clinical, and regulatory teams by authoring documents and managing the document review process
  • Participating in clinical study team and other appropriate development team meetings to provide input regarding deliverables, timelines, and process
  • Coordinating with project team leads regarding appropriate document content
  • Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator brochures, annual reports and submission documents, pharmacology and PK reports, nonclinical summaries, summary documents, briefing documents, and regulatory responses

Requirements

  • Qualifications: Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD preferred
  • Minimum 5 years of medical writing/regulatory experience in the biotech or pharmaceutical industry
  • The medical writer should be familiar with FDA and ICH guidelines and the current AMA Style Manual
  • Experience with regulatory submissions (IND, NDA, MAA, NDS, etc.) in eCTD format
  • Experience authoring /editing Clinical Study Reports and other clinical regulatory documents
  • Excellent written and oral communication and interpretive skills
  • High attention to detail, and excellent proofreading and editing skills
  • High‑level competence in pertinent software (e.g., Word, PowerPoint, EndNote)
  • Knowledge of the drug development process and general knowledge of applied clinical medicine and laboratory interpretation
  • Experience with small molecule drug development is preferred
  • Demonstrated ability in project management, with overlapping priorities and aggressive timelines

 


Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.